DSCSA for Dispensers: At-a-Glance

What does DSCSA stand for?

DSCSA stands for the Drug Supply Chain Security Act, which is Title II of the Drug Quality and Security Act (DQSA).

What is it?

DSCSA mandates a full supply chain traceability system from pharmaceutical manufacturer to pharmacy dispenser for prescription drugs being distributed in the United States.

The law was signed by President Obama in November 2013, providing a national standard for drug security and replacing the patchwork of state-level Pedigree regulations that were in place.

Why is it important?

The World Health Organization estimates that between 1% and 10% of drugs sold around the world are counterfeit, with that number reaching as high as 50% in some countries. DSCSA will help protect patient safety by enabling verification of products, improving the detection of suspect ones, and facilitating product recalls.

Which supply chain segments have a compliance requirement?

Drug manufacturers, wholesale distributors, repackagers, and dispensers who work with prescription products in the U.S. have a requirement.

Who qualifies as a dispenser in the eyes of the law?

Anyone who dispenses prescription products to patients -- including but not limited to pharmacies, clinics, hospitals, physicians, and long-term care facilities – is considered a dispenser.

If your business dispenses to patients but also resells product to distributors or other dispensers, it falls under wholesale distributor requirements.

What does DSCSA mean for my dispenser business?

The law has complex drug tracking, verification, and serialization regulations that impact your business and how you communicate with supply chain partners.

Verify: Retrieve, analyze, and provide TH/TI/TS within two business days during suspect product investigations and recalls; quarantine and investigate any product identified as suspect; and notify the FDA and supply chain partners.

You must also retain product compliance documentation for six years.

DSCSA does notrequire you to store data associated with patient-level prescriptions.

Will additional requirements come later?

In 2020, serialization requirements will phase in, mandating that you purchase and sell only serialized drug products, and store serialization information for 6 years. There will also be enhanced verification processes in 2020.